Method and apparatus for suturing

ABSTRACT

The present invention provides new and useful devices and techniques for use in suturing. These devices and techniques are particularly useful in laparoscopic, arthroscopic, and/or open surgical procedures. A method according to the present invention is characterized by releasably coupling a suture to a suture device, causing the tip of the suture device and a portion of the suture to penetrate a tissue, and releasing the suture from the suture device, so the suture may be drawn through the tissue for completion of a suturing procedure. One type of suturing device according to the invention is characterized by a handle with an elongated shaft with a sharpened tip configured to hold a suture at a selected point on the suture. Another type of device according to the principles of the invention is characterized by new and useful structures and techniques for loading the suture into the device. According to still another aspect of the present invention, different shaped suture tips are provided for the selection of the most effective tip shape for a given application. A suturing device according to the present invention may also be configured for use with a needle point swedged to a suture. Yet another type of suturing device according to the principles of present invention includes a tissue support structure disposed adjacent the sharpened tip, which may move relative to the sharpened tip to facilitate penetration of the tip through a tissue.

RELATED APPLICATION/CLAIM OF PRIORITY

[0001] This Application is related to and claims priority fromProvisional Application Serial No. 60/129,993 entitled “Suture Leaderfor Shuttleless suturing”, filed Apr. 19, 1999.

FIELD OF INVENTION

[0002] The present invention relates to methods and apparatus for use insurgical suturing.

BACKGROUND OF INVENTION

[0003] Suture is often used bring two pieces of tissue together and holdthe tissues as they heal. Needles allow a surgeon to pierce tissue andpull suture through that tissue. In many procedures, there is adequatespace in the wound or incision to manipulate needles and needle holdinginstruments. The move by surgeons toward less invasive and minimallyinvasive surgeries has created the need for instruments to be designedto function in limited space and with longer reaches. Standard surgicalinstruments are being stretched and downsized to pass through tunnels inthe tissue called cannulas or portals measuring as small as 5millimeters in diameter and in a variety of lengths. There is a need forimproved surgical instruments to manipulate and control sutures duringsurgical operations.

SUMMARY OF THE INVENTION

[0004] The present invention provides new and useful devices andtechniques for use in suturing. These devices and techniques areparticularly useful in laparoscopic, arthroscopic, and/or open surgicalprocedures.

[0005] One type of suturing device according to the invention ischaracterized by a handle with an elongated shaft with a sharpened tipconfigured to hold a suture at a selected point on the suture. Severaldifferent types of structures for holding the suture to the sharp tipare provided according to the principles of the invention. For example,one such structure comprises a tapered opening formed in the tip, andconfigured to enable a suture to be wedged and held in the opening. Inanother example, an elongated opening is provided, which may be curved,for holding the suture. In yet another example, a locking mechanism isprovided, which has a locked position for holding the suture, anunlocked position for releasing the suture, and a partially lockedposition for controlled adjustment of the suture position relative tothe tip.

[0006] Another type of device according to the principles of theinvention is characterized by new and useful structures and techniquesfor loading the suture into the device. In one example of this aspect ofthe present invention, a suture may be side-loaded into the device. Thisprovides numerous advantages, including eliminating the need to threadthe suture, and allowing side-release of the suture.

[0007] According to still another aspect of the present invention,different shaped suture tips are provided for the selection of the mosteffective tip shape for a given application. In one example of thisaspect of the present invention, each tip may be detached from thesuturing device and replaced by another tip. In another example of thisaspect of the present invention, the position of each tip is adjustablerelative to the shaft of the suturing device for further refinement ofthe suturing device for a given application.

[0008] A suturing device according to the present invention may also beconfigured for use with a needle point swedged to a suture.

[0009] Yet another type of suturing device according to the principlesof present invention includes a tissue support structure disposedadjacent the sharpened tip, which may move relative to the sharpened tipto facilitate penetration of the tip through a tissue. In one example ofthis aspect of the present invention, a suture is carried through thetissue by the tip as the tip penetrates the tissue. In another exampleof this aspect of the present invention, the tip engages the sutureafter penetration of the tissue, and draws the suture through the tissueas the tip is withdrawn from the tissue.

[0010] A method according to the present invention is characterized byreleasably coupling a suture to a suture device, causing the tip of thesuture device and a portion of the suture to penetrate a tissue, andreleasing the suture from the suture device, so the suture may be drawnthrough the tissue for completion of a suturing procedure.

[0011] These and other features and techniques of the present inventionwill become further apparent from the following detailed description andthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more complete understanding of the present invention may bederived by referring to the detailed description and claims whenconsidered in connection with the following illustrative Figures, whichmay not be to scale. In the following Figures, like reference numbersrefer to similar elements throughout the Figures.

[0013]FIG. 1 is a perspective view of a suturing device in accordancewith the present invention;

[0014]FIG. 2 is a close-up perspective view of the sharpened tip at thedistal end of the suturing device of FIG. 1;

[0015]FIGS. 3-5 illustrate the relative positions of a suture and asuturing device during coupling of a suture with the suturing device inaccordance with the principles of the present invention;

[0016]FIGS. 6A-6B schematically illustrate the manner in which a sutureis trapped and held by an opening in the sharpened tip of a suturingdevice in accordance with the principles of the present invention;

[0017]FIGS. 7-10 illustrate successive steps in applying a suture totissue using a suturing device in accordance with the principles of thepresent invention;

[0018]FIGS. 11-17 schematically illustrate sharpened tips and differentconfigurations for an opening for use in coupling a suture with thesharpened tip in accordance with the principles of the presentinvention;

[0019]FIG. 18-21 schematically illustrate a suturing device with alocking mechanism according to the principles of the present invention;

[0020]FIG. 22 schematically illustrates a sharpened tip with acombination of openings for use in coupling a suture with the sharpenedtip in accordance with the principles of the present inventions;

[0021]FIGS. 23-29 schematically illustrate different configurations fora sharpened tip with an opening for coupling a suture with the sharpenedtip in accordance with the principles of the present invention;

[0022]FIGS. 30-32 schematically illustrate different ways for coupling aneedle with a swedged suture to a suturing device in accordance with theprinciples of the present invention;

[0023]FIG. 33 schematically illustrates another way for coupling asuture to a suturing device in accordance with the principles of thepresent invention; and

[0024]FIG. 34-36 illustrate a suture device in which a tissue supportdevice is provided in accordance with the principles of the presentinvention.

DETAILED DESCRIPTION

[0025] As set forth above, the present invention provides several typesof devices and techniques which are useful in suturing, for example inconnection with laparoscopic, arthroscopic, and/or open surgicalprocedures. Examples of devices and techniques according to theprinciples of the present invention are described below in connectionwith particular embodiments, but it will be clear to those skilled inthe art that aspects of the present invention found in one example maybe practiced alone or in combination with (or even in lieu of) devicesand techniques of the other examples.

[0026] One type of suturing device in accordance with the presentinvention is shown in FIG. 1. Suturing device 100 has a handle 102, ashaft 104 connected to the handle, and a tip 106 connected to the other(distal) end of the shaft. Typically, the handle 102 may be 4 to 6inches long, and the shaft 104 may typically be from 1 to 24 inches,depending on the application. The shaft is typically 2 to 3 millimetersin diameter and formed of a rigid substance Tip 106 includes a sharpenedpoint 108 and an eyelet (or opening) 110.

[0027]FIG. 2 shows a close-up view of tip 106. Tip 106 has a curved,hook-like shape for convenient delivery of a suture, as discussedfurther below. Eyelet 110 has an top portion 112 configured to be widerthan a suture used in connection with the suturing device, and anarrowed bottom portion 114 for trapping the suture.

[0028] Referring now to FIGS. 3 through 6B, a method according to thepresent invention is shown. Suture 302 is threaded through eyelet 110 asshown in FIG. 3 and 4 until a selected length of suture (labeled “d”) isextended through suturing device 100 as shown in FIG. 4. Preferably,length d is about 2 inches. Once the selected point of suture is ineyelet 110, length d is drawn downward, as shown in FIG. 5, trapping thesuture in eyelet 110. FIG. 6A shows the position of the suture in thewider top portion 112 of eyelet 110 prior to the drawing downward step.6B shows the suture wedged into the narrowed bottom portion 114 ofeyelet 110 after the downward drawing step of FIG. 5. The suture in FIG.6B is thus trapped in the narrowed bottom portion 114 in accordance withone aspect of the invention.

[0029]FIGS. 7 through 10 show the use of the above described embodimentof the present invention in the repair of a gap 702 formed in tissue704. As shown in FIGS. 7 and 8, suturing device 100 with suture 302 ispartially inserted into a portion of tissue 704. Sharpened tip 106 ofsuturing device 100 penetrates tissue 704, thereby delivering suture 302to the other side of tissue 704. A second tool 902 (FIG. 9) is used toassist in the release of suture 302 from eyelet 110, and to draw theshort end of suture 302 the rest of the way through tissue 704 and fullydisengage suture 302 from device 100 (See FIG. 10). Exhibit A showscolor illustrations similar to FIGS. 7 through 10 and which may moreclearly illustrate the contrast between the tool, the suture, and thetissue that is being sutured.

[0030]FIG. 11 shows a close-up of a tapered eyelet 110 of the typedescribed in FIGS. 1 through 10, and further illustrating theorientation of the tapered eyelet 110 relative to the sharpened tip 106.

[0031]FIG. 12 shows a close-up of a sharpened tip 1202 with analternative embodiment of an eyelet 1204 in accordance with theprinciples of the present invention. Eyelet 1202 has a tapered centralportion 1206 which may trap a suture from either the top wider portion1208 or the bottom wider portion 1210 of eyelet 1204. One advantage ofthis embodiment is that the device operator may disengage suture 302from device 100 either by pulling the suture towards the wider topportion 1208 or the wider bottom portion 1210. It will be clear to oneskilled in the art that this embodiment of the present inventionprovides added flexibility in the manner in which the suture can bereleased.

[0032]FIG. 13 shows a close-up of a sharpened tip 1302 with anotheralternative embodiment of an eyelet 1304 in accordance with theprinciples of the present invention. Eyelet 1304 is configured forside-loading of the suture into the eyelet. Eyelet 1304 is advantageouswhere the end of a suture is frayed, or it is otherwise difficult ortime-consuming to pass lengthwise through an eyelet (as shown in FIGS. 3and 4). The eyelet configuration shown in FIG. 13 allows for very easyloading, sliding, and release of the suture from the suturing device.

[0033]FIG. 14 shows another sharpened tip 1402 with still anotherembodiment of an eyelet 1404 with the feature of side-loading of asuture according to the principles of the present invention. TheT-shaped configuration of eyelet 1404 substantially traps the suture ineyelet 1404 while allowing the suture to slide lengthwise through theeyelet.

[0034]FIG. 15 shows yet another sharpened tip 1502 with anotherconfiguration of an eyelet 1504 with side-loading capability accordingto the principles of the present invention. Eyelet 1504 is configuredwith a deep diagonal slot 1506 which substantially traps the suturewhile allowing the suture to slide lengthwise through the eyelet.

[0035]FIG. 16 shows yet another sharpened tip 1602 with anotherembodiment of an eyelet 1604 with side-loading capability according tothe principles of the present invention. In FIG. 16, eyelet 1604 has atapered configuration so that a suture may be side-loaded into asuturing device and then wedged into the tapered portion of the eyeletfor improved trapping of the suture.

[0036]FIG. 17 shows yet another sharpened tip 1702 with anotherembodiment of an eyelet 1704 with a side-loading capability according tothe principles of the present invention. In FIG. 17, eyelet 1704 has anelongated and curved configuration for substantially trapping a suturewhile allowing the suture to slide lengthwise through the eyelet. Theelongated and curved configuration of the eyelet makes it very unlikelythat a suture will be unintentionally released from the suturing device.

[0037]FIGS. 18 through 21 illustrate a suturing device with a lockingmechanism for trapping a suture in an opening in a sharpened tip inaccordance with the principles of present invention. As shown in FIG.18, suturing device 1800 has a handle 1802 with locking mechanism button1804, shaft 1806, and sharpened tip 1808.

[0038]FIG. 19 illustrates a close-up of sharpened tip 1808, havingopening 1902 and locking element 1904. Locking element 1904 iscontrolled by the device operator with button 1804 (FIG. 18). Lockingelement 1804 may be selectively placed in (1) an open position forinserting a suture into an opening in the sharpened tip and for releaseof the suture from the opening in the sharpened tip; (2) at least onepartially closed position for capturing the suture and for controlledadjustment of the suture relative to the tip; and (3) a locked positionfor trapping a suture in the opening in the sharpened tip at a selectedpoint.

[0039]FIG. 20 further illustrates the use of the locking mechanism inaccordance with the principles of the invention. FIG. 20 shows aschematic view of the sharpened tip 1808 with opening 1902. Sharpenedtip 1808 has side-loading capability and locking element 1904, which canbe selectively placed in any of the foregoing positions by movement ofthe locking element in the direction of arrow 2002. When a suture isfirst side-loaded, locking element 1904 is in the open position as shownin FIG. 20. As locking element 1904 is pushed forward and theside-opening 2004 is blocked-off, the suture is captured in the tip, butis not yet trapped in a particular position. In this state, the suturemay slide lengthwise relative to sharpened tip 1808, but may not beremoved from sharpened tip 1808 unless the full length of the the sutureis drawn through opening 1902. As element 1904 is moved further forward,it engages the suture with a light amount of friction, giving the deviceoperator the ability to control the lengthwise movement of the suturewithout damaging the suture. Finally as locking element 1904 is pushedfully forward, the suture becomes wedged in opening 1902, and fixed in alocked position. Release of the suture is achieved by moving the lockingbutton to move the locking element away from the locked position.

[0040] In the embodiment of the present invention shown in FIG. 21, thelocking element moves in the same manner as in FIG. 20, and the samelocking principles apply, but no side-loading capability is provided.

[0041] Referring to FIG. 22, various combinations of eyelets may beformed on a sharpened tip in accordance with the principles of thepresent invention. For example, a round eyelet 2202 may be formed inaddition to a deep diagonal slot 2204 on a device tip to allow selectionof fully enclosing a suture (round eyelet) or side-loading of a suturewith substantial trapping of the suture (deep diagonal slot) on the sametool. As another example, the eyelet with a tapered central portion asshown in FIG. 12 may also be combined with a side-loading feature. Theseand other combinations in accordance with the principles of theinvention are intended to be included within the scope of the presentinvention.

[0042]FIGS. 23 through 29 show different sharpened tips for use indifferent applications of the present invention. The sharpened tip 2302illustrated in FIG. 23 extends substantially straight and forward fromthe distal end of the device shaft. Alternatively, as shown in FIG. 24,a the sharpened tip 2402 may be angularly bent relative to the shaft ina selected direction, and angled to a side. As illustrated in FIG. 25,and sharpened tip 2502 may be further bent so that the distal portion ofthe tip generally points towards the proximal end of the shaft.

[0043] Referring now to FIG. 26, an alternative embodiment according thepresent invention is shown wherein a sharpened tip 2602 is curved atleast partially about the distal end of the shaft.

[0044] In a further embodiment according to FIG. 27, a sharpened tip2702 is formed with at least one spiral loop at the distal end of theshaft. In the illustrated example, the spiral shaped tip 2702 has about1.5 loops. According to this embodiment of the present invention, with asuture held near the front of the spiral (see location of eyelet 2704),the suture may be passed through a tissue two or more times prior toreleasing the stitch from a suturing device.

[0045] As shown in FIG. 28, a sharpened tip 28 may be configured toextend directly to one side of the distal end of the shaft.

[0046] Further, as shown in FIG. 29, a sharpened tip 2902 may beconfigured to extend at least partially forward from the. distal end ofthe shaft with a concave configuration.

[0047] Each of the above sharpened tip configurations may be selectedfor a particular application to allow a surgeon to pierce tissue inprecisely the position chosen for the optimal re-approximation oftissue. Further, each of the above sharpened tip configurations may becombined with the other various aspects of the present invention toprovide a wide selection of combinations to best pass suture through asubstrate. For example, each of the above sharpened tip configurationsmay be combined with any of the eyelet configurations. Moreover, any ofthe eyelets could have side-loading capability and/or a lockingmechanism.

[0048] In accordance with a further principle of the present invention,each tip may be configured for adjustability relative to the axis of thesuturing device shaft, for providing further flexibility as to theorientation in which the suture may be applied to a gap in tissue. Forexample, the angle of the tip in FIG. 24 relative to the shaft may beadjusted at point in the direction of arrow 2404. Similarly, the loopedtip in FIG. 27 may be rotated in the direction of arrow 2706. Each ofthe sharpened tips disclosed thus may be pivoted, rotated, or otherwisefurther adapted for improved application of the sharpened tip and thesuture.

[0049] In accordance with a further principle of the present invention,various tips may be removed from the suturing device and replaced withan alternative tip or with a new, sharper tip. For example, referring toFIG. 24, the tip may be removed at point 2406 and replaced with the tipas shown in FIG. 25. Alternatively, the tip may be detached at otherpositions on the suturing device, such as by removing the shaft at point116 (FIG. 1), and replacing it with a shaft carrying a differentlyshaped tip.

[0050] Referring now to FIGS. 30 through 32, further embodiments of thepresent invention configured for use with a needle point swedged to asuture are shown. As shown in FIG. 30, suture 3002 with needle tip 3004may be side-loaded into a suturing device with a shaft 3006 with acurved distal end portion 3008. In accordance with this aspect of theinvention, needle tip 3004 is sharpened and acts to penetrate and leadsuture 3002 through a tissue. Once the tissue is punctured, the needletip is grasped with a suture grasper (e.g. similar to second tool 902 inFIG. 9) and removed from the shaft in the direction of arrow 3010. Theshaft is withdrawn and the suture is pulled through the tissue tocomplete the stitch. This embodiment also allows the simple replacementof sharp needles for tips that may have become dull. Further, tissueabrasion associated with pulling the short end of a suture through anopening already containing a length of suture is eliminated.

[0051] The shaft as in FIG. 30 may be modified as a cannula with thesuture passing through a partial length of the device (FIG. 31) or thefull length of the device (FIG. 32). These structures are advantageousin reducing or eliminating the amount of loose suture from the procedurearea. Each of the devices in FIGS. 30 through 32 will preferably have aconfiguration for firmly holding the needle tip while it is piercing thetissue.

[0052] Referring to FIG. 33, alternatively, a suturing device 3300 mayhave a sharpened tip 3302, as in FIGS. 1 through 29, and be configuredas a cannula with the suture passing through the full length of thedevice with a section 3304 protruding from the tip, in position forgrasping as soon as the sharpened tip pierces a substrate. Section 3304is located behind the first portion of the tip sharpened tip thatpierces a tissue, so that the outwardly extending portion is carriedthrough the tissue which has been pierced by the sharpened tip.

[0053] Referring now to FIG. 34, another embodiment of the inventionincluding a tissue support structure 3402 disposed adjacent sharpenedtip 3404 is shown (Exhibit B is a color illustration similar to FIG. 34,but also showing a suture). Tissue support structure 3402 is located onrotatable sheath 3406, which encases a shaft (shaft is not shown but isattached to handle 3408 and tip 3404). Rotatable sheath 3406 ispreferably rotated by turning serrated handle 3410. Referring briefly toFIG. 35, a close-up view of the distal tip of a suturing deviceaccording to the principles of FIG. 34 is shown.

[0054] On occasion, the tissue to be sutured is difficult to pierce andrequires pressure from behind to “push” the tissue against the sharpenedtip. Use of tissue support structure 3402 is accomplished by positioninga portion of tissue to be sutured in between sharpened tip 3404 andtissue support structure 3402. The sharpened tip is rotated through thetissue while the tissue support rotates in an opposite direction,forcing the tissue against and to be pierced by the sharpened tip. Therelative rotational motion between tissue support structure 3402 andsharpened tip 3404 provides the device operator with tactile feedback asto the amount of force being applied to a tissue.

[0055] In accordance with the principles of the present invention,tissue support structure 3402 and sharpened tip 3404 are suitablyconfigured to approach and engage a portion of tissue from a broad rangeof angles or positions. Combination of the various sharpened tipconfigurations in accordance with the present invention and theadjustability of those tips with the tissue support structure providesan even broader range of options for engaging a tissue between asharpened tip and tissue support structure 3402.

[0056] With continue reference to FIG. 35, a suture 302 is connectedwith the sharpened tip and passed through the tissue as the sharpenedtip pierces the tissue. After piercing, the suture is grasped on theother side of the tissue, as described above, released from thesharpened tip, and then pulled through the tissue for further use insuturing.

[0057] Referring now to FIG. 36, an alternative configuration fordrawing a suture through a tissue is disclosed (Exhibit C is a colorillustration of the elements of FIG. 36). A suture 302 is connected witha sling 3602 in a tissue support device 3604. The sharpened tip piercesthe tissue with the assistance of the tissue support device, and engagesthe suture as the sharpened tip is drawn back through the tissue and thesuturing device is rotated open. In this way, if a suture is preferablyapplied from a side of a tissue inaccessible to the sharpened tip, thesharpened tip may be engaged from the opposite (and accessible) side ofthe tissue, and then made to draw the suture back through the tissue.

[0058] The present invention has been described above with reference topreferred embodiments. However, those skilled in the art having readthis disclosure will recognize that changes and modifications may bemade to the preferred embodiment without departing from the scope of thepresent invention. For example, the combination of the various openingconfigurations with the configurations of the sharpened tip is clearlycontemplated by this disclosure. Similarly, the use of the variouseyelets, tip configurations, and locking mechanisms with the differenttissue support features is intended. These and other changes ormodifications are intended to be included within the scope of thepresent invention, as expressed in the following claims.

1. A suturing device comprising: a handle; an elongated shaft attachedto said handle; and a sharpened tip on said elongated shaft, saidsharpened tip configured to trap a suture at a selected point.
 2. Asuturing device as defined in claim 1, wherein said sharpened tipincludes an opening configured to trap a suture at a selected point. 3.A suturing device as defined in claim 2, wherein a least a portion ofthe opening is dimensioned to wedge and hold a suture in the selectedposition
 4. A suturing device as defined in claim 3, wherein saidopening comprises a central portion which has said taperedconfiguration.
 5. A suturing device as defined in claim 2, wherein saidopening comprises a tapered opening.
 6. A suturing device as defined inclaim 2, wherein said opening comprises an elongated opening.
 7. Asuturing device as defined in claim 6, wherein at least a portion ofsaid elongated opening is curved.
 8. A suturing device as defined inclaim 1, wherein said sharpened tip includes an opening; and a lockingmechanism having at least a locked position and an unlocked position,said locking mechanism when in said locked position being configured totrap a suture in said opening.
 9. A suturing device as defined in any ofclaims 2-8, wherein the suture comprises a length of material, andwherein said opening is configured to allow the suture to passlengthwise through said opening.
 10. A suturing device as defined inclaim 9, wherein said opening is further configured to allow the sutureto be side-loaded into said opening.
 11. A suturing device as defined inclaim 1, wherein said sharpened tip includes an opening into which asuture can be inserted, and wherein said opening is configured to allowthe suture to be side loaded into said opening.
 12. A suturing device asdefined in claim 1, wherein said sharpened tip has a hookedconfiguration.
 13. A suturing device as defined in claim 1, wherein saidsharpened tip is angularly bent relative to said shaft in a selecteddirection.
 14. A suturing device as defined in claim 1, wherein saidsharpened tip is configured with at least one spiral loop at the distalend of the shaft.
 15. A suturing device as defined in claim 1, whereinsaid sharpened tip is bent so the distal tip generally points towardsthe proximal end of the shaft.
 16. A suturing device as defined in claim1, wherein said sharpened tip is curved at least partially about thedistal end of the shaft.
 17. A suturing device as defined in claim 1,wherein said sharpened tip extends at an angle and to one side of thedistal end.
 18. A suturing device as defined in claim 1, wherein saidsharpened tip extends at least partially forward from the distal endwith a concave configuration.
 19. A suturing device as defined in claim1, wherein said sharpened tip extends substantially straight and forwardfrom said distal end.
 20. A suturing device as defined in claim 1,wherein said sharpened tip is selectively moveable relative to saidshaft.
 21. A suturing device as defined in claim 1, wherein saidsharpened tip is selectively detachable from said shaft.
 22. A suturingdevice comprising: a handle; an elongated shaft attached to said handleat a proximal end of said shaft; and a detachable needle at a distal endof said elongated shaft, said needle having a suture attached thereto.23. A suturing device as defined in claim 22, wherein said distal endhas a hooked configuration.
 24. A suturing device as defined in claim22, wherein said distal end is angularly bent relative to said shaft ina selected direction.
 25. A suturing device as defined in claim 22,wherein said distal end is configured with at least one spiral loop atthe distal end of the shaft.
 26. A suturing device as defined in claim22, wherein said distal end is bent so the distal tip generally pointstowards the proximal end of the shaft.
 27. A suturing device as definedin claim 22, wherein said distal end is curved at least partially aboutthe distal end of the shaft.
 28. A suturing device as defined in claim22, wherein said distal end extends at an angle and to one side of thedistal end.
 29. A suturing device as defined in claim 22, wherein saiddistal end extends at least partially forward from the distal end with aconcave configuration.
 30. A suturing device as defined in claim 22,wherein said distal end extends substantially straight and forward fromsaid distal end.
 31. A suturing device as defined in claim 22, whereinsaid needle and suture are detachably affixed to said suturing device bythreading the suture through a portion of said suturing device.
 32. Asuturing device as defined in claim 22, wherein said needle and sutureare detachably affixed to said suturing device by threading the suturethrough at least the distal end and the shaft of said suturing device.33. A suturing device as defined in claim 22, wherein said needle andsuture are side-loaded into said suturing device.
 34. A suturing devicecomprising: a handle; an elongated shaft attached to said handle at aproximal end of said shaft; a sharpened tip at a distal end of saidelongated shaft; and a tissue support device disposed adjacent saidsharpened tip, configured to move relative to said sharpened tip tofacilitate penetration of said sharpened tip through a tissue.
 35. Asuturing device as defined in claim 34, wherein a suture is connectedwith said sharpened tip and moves with the sharpened tip as thesharpened tip penetrates through the tissue.
 36. A suturing device asdefined in claim 34, wherein a suture is connected with said tissuesupport device, and is located to be engaged by said sharpened tip assaid sharpened tip is withdrawn from the tissue.
 37. A method ofdelivering a suture comprising: providing a suture device; releasablycoupling a suture with the distal end of said suture device; penetratinga substrate with the distal end of said suture device such that saidsuture is partially passed through the substrate; and releasing thesuture from said suture device.
 38. A method as defined in claim 37,wherein said step of releasably coupling a suture with the distal end ofsaid suture device comprises releaseably trapping the suture in anopening at the distal end of said suture device.
 39. A method as definedin claim 37, wherein the opening is configured to trap and hold asuture, and said step of releasably coupling comprises releasablytrapping and holding the suture in the opening.
 40. A method as definedin claim 37, wherein a locking mechanism associated with the opening hasa locked position in which it releasably traps the suture in theopening, at least a portion of the suture being disposed in the opening,and said step of releasably coupling comprises placing said lockingmechanism in its locked position.
 41. A method as defined in any ofclaims 38 through 40, wherein said step of releasably coupling comprisesthe step of side-loading the suture into the opening.
 42. A method asdefined in claim 37, wherein the distal end of said suture device isselectively adjustable relative to the suture device.
 43. A method asdefined in claim 37, wherein the distal end of said suture device isselectively detachable from the suture device.
 44. A method as definedin claim 43, wherein a differently shaped distal end may be attached tothe distal end of said suture device.
 45. A method as defined in claim37, wherein a detachable needle is disposed at the distal end of thesuture device, said needle having a suture attached thereto, and whereinsaid step of penetrating a substrate with the distal end of the suturecomprises penetrating the substrate with said detachable needle.
 46. Amethod as defined in claim 37, wherein a second penetrating step isperformed through said substrate with said distal end of said suturedevice prior to said releasing step.
 47. A method as defined in claim37, wherein the distal end comprises a sharpened tip, a tissue supportdevice is disposed adjacent the sharpened tip, and said step ofpenetrating a substrate comprises locating the tissue support deviceadjacent a selected portion of tissue and moving the sharpened tiprelative to the tissue support device to facilitate penetration of thesharpened tip through the selected portion of tissue.
 48. A method asdefined in claim 47, wherein a suture is connected with the sharpenedtip and moves with the sharpened tip as the sharpened tip penetratesthrough the tissue.
 49. A method of delivering a suture comprising:providing a suturing device having a sharpened tip configured topenetrate a tissue, a tissue support device disposed to be locatedadjacent a selected portion of tissue, and being moveable relative tothe sharpened tip to facilitate penetration of the sharpened tip throughthe selected portion of tissue and to enable the sharpened tip to bewithdrawn from the selected portion of tissue; providing a suturedisposed to be engaged by the sharpened tip as the sharpened tip isbeing withdrawn from the selected portion of tissue; locating the tissuesupport device adjacent a selected portion of tissue and moving thesharpened tip relative to the tissue support device to pierce theselected portion of tissue, and engaging the suture with the sharpenedtip as the sharpened tip is withdrawn from the selected portion oftissue; and releasing the suture from the sharpened tip after thesharpened tip has been withdrawn from the selected portion of tissue.50. A method as defined in claim 49, wherein the step of moving thesharpened tip relative to the tissue support device comprises rotatingthe tissue support device and the sharpened tip relative to each otherso that the sharpened tip rotates towards the tissue support device asthe sharpened tip pierces the tissue and rotates away from the tissuesupport device as the sharpened tip is withdrawn from the selectedportion of tissue, and engaging the suture with the sharpened tip anddrawing the suture through the selected portion of tissue as thesharpened tip rotates away from the tissue support device and iswithdrawn from the selected portion of tissue.
 51. A suturing devicecomprising: a handle; an elongated shaft attached to said handle; asharpened tip on said elongated shaft, said sharpened tip beingconfigured to engage a suture; and a locking mechanism having at least alocked position and an unlocked position, said locking mechanism when insaid locked position being configured to hold the suture in a selectedposition.
 52. A suturing device as defined in claim 51, wherein saidlocking mechanism has at least one partially closed position forcapturing the suture and for controlled adjustment of the suturerelative to the sharpened tip.
 53. A suturing device comprising: ahandle; an elongated shaft attached to said handle; a sharpened tip onsaid elongated shaft, said sharpened tip having an opening configured toallow the suture to be side-loaded onto said device.
 54. A suturingdevice as defined in claim 53, wherein said opening comprises a taperedopening.
 55. A suturing device comprising: a handle; an elongated shaftattached to said handle; a sharpened tip on said elongated shaft, saidsharpened tip having a piercing portion configured to pierce tissueduring a suturing procedure; and a suture coupled with said sharpenedtip, said suture having a suture portion extending outward from saidsharpened tip to permit said suture to be grasped and manipulatedrelative to said sharpened tip, said suture portion disposed to becarried by the sharpened tip through tissue which has been pierced bysaid piercing portion.